Universal Brain Receives FDA 510(k) Clearance for UB ERP System, Advancing Objective Brain Function Assessment in Mental Health Care
Universal Brain, a neurotechnology company focused on developing objective tools to measure brain function for mental health applications, has announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its proprietary UB ERP System. The regulatory milestone represents a significant advancement for the company as it prepares to introduce a rapid, neuroscience-based brain assessment platform into routine psychiatric practice and clinical research.
The UB ERP System combines electroencephalography (EEG) technology with event-related potentials (ERPs) to provide clinicians and researchers with objective measurements of brain function. By integrating a proprietary dry-electrode EEG wearable with the company’s Neurotique™ ERP software, the platform is designed to simplify traditional EEG testing while delivering fast and standardized assessments of neural activity.
According to Universal Brain, the FDA clearance marks an important step toward addressing one of psychiatry’s longstanding challenges: the lack of objective biological measurements that can complement traditional symptom-based evaluations. The company believes its technology has the potential to improve clinical decision-making, support personalized treatment strategies, and accelerate research into new therapies for psychiatric and neurological disorders.
Moving Beyond Symptom-Based Psychiatry
For decades, psychiatric diagnosis and treatment have relied primarily on clinical interviews, patient-reported symptoms, behavioral observations, and standardized rating scales. While these approaches remain essential to mental health care, they often provide limited insight into the underlying biological processes contributing to psychiatric illness.
Unlike many other medical specialties that routinely utilize laboratory tests or imaging to guide diagnosis and treatment, psychiatry has historically lacked objective biomarkers capable of measuring brain function in everyday clinical practice.
As a result, treatment selection frequently involves a trial-and-error process in which clinicians prescribe medications or therapies based largely on symptom patterns, followed by weeks or months of monitoring to determine whether patients respond.
Universal Brain aims to complement these traditional approaches by providing clinicians with rapid, objective measurements of neural activity that may help characterize how individual patients’ brains are functioning.
The company believes integrating neuroscience-based assessments into psychiatric care could eventually support more personalized treatment decisions while improving the understanding of disease mechanisms.
A Rapid EEG and ERP Assessment Platform
At the center of Universal Brain’s technology is the UB ERP System, which combines two established neuroscience techniques into an integrated clinical platform.
Electroencephalography records the brain’s electrical activity using sensors placed on the scalp, while event-related potentials measure specific neural responses triggered by sensory, emotional, or cognitive stimuli.
Traditionally, EEG testing often requires extensive preparation, conductive gels, lengthy setup procedures, and specialized technical staff.
Universal Brain has sought to simplify this process through the development of a proprietary dry-electrode EEG wearable, eliminating many of the practical limitations associated with conventional EEG systems.
The wearable operates in conjunction with the company’s Neurotique™ ERP software, which captures, analyzes, and presents brain function data within a streamlined workflow.
According to the company, clinicians can complete the entire assessment process—from device placement through analyzed results—in less than five minutes, significantly reducing the complexity of brain function testing.
Objective Measurement of Cognitive and Emotional Processing
Rather than evaluating symptoms alone, the UB ERP System measures neural responses generated during carefully designed cognitive and emotional tasks.
These objective brain signals may provide insight into how different neural systems are functioning and how they change during treatment.
Potential applications include evaluating brain activity associated with:
- Attention
- Cognitive processing
- Emotional regulation
- Information processing
- Neural response timing
By capturing these physiological responses, the company hopes to provide clinicians with additional information that complements traditional psychiatric evaluations.
Universal Brain believes that measuring brain function directly may ultimately help distinguish between patients who appear clinically similar but exhibit different underlying patterns of neural activity.
FDA Clearance Marks a Major Milestone
Founder and Chief Executive Officer Dr. Kazu Okuda described the FDA clearance as a significant achievement for both the company and the broader field of psychiatric neuroscience.
He explained that the approval represents meaningful progress toward bringing objective brain function measurement into everyday psychiatric practice.
According to Dr. Okuda, the ability to measure neural responses during cognitive and emotional tasks offers an opportunity to better understand how each patient’s brain is functioning rather than relying exclusively on reported symptoms.
He noted that Universal Brain’s long-term vision is to enable more personalized treatment decisions while accelerating the development of improved therapies for patients living with mental health disorders.
The company believes objective brain measurements could eventually become a routine component of psychiatric evaluation alongside traditional clinical assessments.
Applications in Clinical Practice and Drug Development
Universal Brain is positioning its platform for use across both routine patient care and psychiatric clinical research.
Within clinical practice, potential future applications include:
- Supporting treatment selection
- Monitoring patient response over time
- Assessing changes in brain function during therapy
- Providing objective measurements alongside symptom ratings
The company is also developing the technology for use in central nervous system (CNS) drug development.
Objective brain biomarkers may help pharmaceutical companies better evaluate investigational therapies, improve patient selection, and monitor treatment effects during clinical trials.
Universal Brain believes these capabilities could contribute to more efficient development of new psychiatric medications by providing measurable indicators of neural function.
New Depression Studies Underway
To further validate its technology for clinical use, Universal Brain has launched two new multicenter studies focused on patients with depression.
United States Study
The U.S. investigation is being conducted in collaboration with Adams Clinical research sites located in Boston and New York.
Researchers will evaluate brain function before and after initiation of first-line antidepressant therapy.
The primary objective is to identify biomarkers capable of predicting which patients are most likely to respond to specific antidepressant treatments.
If successful, such biomarkers could eventually support more personalized prescribing decisions while reducing delays associated with unsuccessful medication trials.
Japan Study
A second multicenter longitudinal study is being conducted across leading hospitals in Japan.
Participants will be followed for 24 weeks after beginning treatment for depression.
Investigators aim to identify objective changes in brain function associated with antidepressant response over time.
Together, these studies are expected to generate valuable data supporting the continued development of Universal Brain’s platform for precision psychiatry.
Strengthening Scientific Leadership
Alongside the FDA clearance, Universal Brain announced the appointment of Dr. K. Luan Phan as Chief Medical Advisor.
Dr. Phan currently serves as Chair of Psychiatry at The Ohio State University College of Medicine and is internationally recognized for his research in psychiatric neuroscience and neuroimaging.
He believes objective measurement of brain function has the potential to fundamentally transform psychiatric diagnosis and treatment.
According to Dr. Phan, Universal Brain’s rapid ERP platform brings sophisticated neuroscience into routine clinical practice in a practical manner that has not previously been possible.
He noted that the technology may allow clinicians to move beyond symptom checklists and begin understanding the underlying neural systems contributing to individual patients’ illnesses while monitoring how those systems respond to treatment.
His appointment further strengthens the company’s scientific and clinical leadership as commercialization approaches.
Government Funding Supports Continued Development
Universal Brain has also secured a $2 million grant from the Japan Agency for Medical Research and Development (AMED) through its Next-Generation Medical Device Development Project.
The funding will support:
- Multicenter clinical studies
- Technology validation
- Commercialization activities
- Continued development of objective brain biomarkers
The grant reflects growing international interest in technologies capable of improving diagnosis and treatment for mental health disorders through objective biological measurements.
Preparing for Commercial Launch
Following FDA clearance, Universal Brain is preparing for the commercial introduction of the UB ERP System later this year.
The company plans to continue generating large-scale clinical datasets to strengthen the predictive capabilities of its platform across multiple psychiatric interventions.
Future research will focus on expanding the use of objective brain function assessment beyond depression into additional psychiatric and neurological conditions.
Potential areas of investigation may include anxiety disorders, bipolar disorder, schizophrenia, cognitive disorders, and other diseases involving altered brain function.
By building comprehensive datasets linking neural measurements with clinical outcomes, Universal Brain hopes to develop increasingly accurate biomarkers capable of supporting individualized treatment strategies.
Advancing Precision Psychiatry
The FDA 510(k) clearance of the UB ERP System represents an important step toward integrating objective neuroscience into routine mental health care. While psychiatric diagnosis has traditionally relied on clinical observation and patient-reported symptoms, advances in neurotechnology are creating new opportunities to directly measure brain function in ways that are practical for everyday clinical use.
With its rapid dry-electrode EEG platform, proprietary ERP software, ongoing multicenter validation studies, and growing scientific collaborations, Universal Brain aims to make objective brain-function assessment a routine component of psychiatric practice and CNS drug development. As additional clinical evidence emerges, the company believes its technology could help support more precise diagnosis, improve treatment selection, enhance monitoring of therapeutic response, and ultimately contribute to better outcomes for patients living with psychiatric and neurological disorders.
About Universal Brain
Universal Brain is a neurotechnology company developing the first scalable platform for objective brain function measurement in psychiatry. Using rapid EEG acquisition and validated neuroscience-based assessments, the company’s platform enables rapid and reliable assessment of brain function. Universal Brain is working to support brain-based monitoring, patient classification (“neurotyping”), and personalized treatment decisions for psychiatric and neurological conditions. Founded in 2022, Universal Brain is headquartered in San Francisco.